NCT06049667招募中1 期
A Phase I Clinical Trial to Evaluate the Safety, Tolerability, Pharmacokinetic/Pharmacodynamic Characteristics and Preliminary Efficacy of NTQ2494 Tablets in Patients With Advanced Hematological Malignancies
Nanjing Chia-tai Tianqing Pharmaceutical1 个研究点 分布在 1 个国家目标入组 72 人开始时间: 2023年8月7日最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 发起方
- 入组人数
- 72
- 试验地点
- 1
- 主要终点
- Maximum tolerance dose (MTD) and dose limiting toxicity (DLT)
研究概览
简要总结
NTQ2494 tablet, an anti-tumor molecular targeted drug, is an AXL kinase inhibitor.
The objectives were to evaluate the safety and tolerability, PK characteristics and preliminary efficacy of NTQ2494 tablets in patients with advanced hematological malignancies.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •≥18 years in age, male or female.
- •Relapsed/refractory AML patients.
- •ECOG performance status score is 0 to
- •Life expectancy of at least 3 months.
- •Adequate bone marrow and good organ function.
- •Ability to understand the purpose and risks of the study and the willingness to sign a written informed consent document.
排除标准
- •Receiving anticancer therapy including immunotherapy, targeted therapy, endocrine therapy, radiotherapy and chemotherapy within 2 weeks or 5 half-lives (whichever is longer) prior to starting study treatment.
- •Receiving any other investigational agents within 4 weeks prior to starting study treatment.
- •Having major surgery within 4 weeks prior to starting study treatment, or intended to undergo surgery during the trail.
- •AML with any of the following: 1) acute promyelocytic leukemia; 2) AML with blast crisis of chronic myelogenous leukemia; 3) central nervous system leukemia.
- •Prior or current other malignancy (except cured noninvasive basal cell or squamous cell skin cancer and/or other cured carcinoma in situ; except for other malignancies that have achieved clinical cure for > 5 years and have not recurred within 5 years).History of severe cardiovascular or cerebrovascular disease.
- •Use of strong inhibitors or strong inducers of CYP3A4 or P-gp within 7 days prior to starting study treatment.
- •Receiving (attenuated) live vaccines within 4 weeks prior to starting study treatment and/or planning to receive (attenuated) live vaccines during the trial.
- •With unresolved clinically significant non-hematological toxicities from prior AML therapy (chemotherapy, targeted therapy, immunotherapy, radiotherapy and surgery), defined as any grade 2 or higher grade (CTCAE v5.0), alopecia and other events that are tolerable as judged by the investigator.
- •Patients who have received previous allogeneic hematopoietic stem cell transplantation; or received autologous hematopoietic stem cell transplantation within 3 months prior to starting study treatment.
- •Unable to swallow oral tablets, or other conditions seriously affecting gastrointestinal absorption judged by the investigator.
- •Patients with uncontrolled infections unsuitable for the trail judged by the investigator.
- •Known infection with hepatitis B, hepatitis C, HIV or Syphilis.
- •Known alcohol or drug dependence.
- •Patients with mental disorders or poor compliance.
- •Patients with a previous history of severe allergy to any drug or food.
- •Lactating or pregnant female, and females or males (or partners) who plan to pregnant and do not agree to use adequate contraception for the duration of the trail and up to 3 months after completion of the last study treatment.
- •Other reasons judged by the investigator that the patients unsuitable for the trail.
研究组 & 干预措施
NTQ2494
Experimental
For each dose level, multiple doses of NTQ2494 tablets will be administered as 28-day treatment (per cycle).
干预措施: NTQ2494 tablet (Drug)
结局指标
主要结局
Maximum tolerance dose (MTD) and dose limiting toxicity (DLT)
时间窗: 30 days
MTD is defined as the maximum dose level at which no more than 1 of 3 participants experience a DLT within the days of single dose and the first 28 days of multiple doses in dose escalation part.
次要结局
- CLz/F of single dose(At the end of Cycle 1 (each cycle is 28 days))
- λz of single dose(At the end of Cycle 1 (each cycle is 28 days))
- Css,max of first 28 days of multiple doses(At the end of Cycle 1 (each cycle is 28 days))
- AUC0-∞ of single dose(At the end of Cycle 1 (each cycle is 28 days))
- Tmax of single dose(At the end of Cycle 1 (each cycle is 28 days))
- Recurrence-free survival (RFS)(through study completion, an average of 1 year)
- t1/2z of single dose(At the end of Cycle 1 (each cycle is 28 days))
- Rac of AUC and Cmax of first 28 days of multiple doses(At the end of Cycle 1 (each cycle is 28 days))
- DF of AUC and Cmax of first 28 days of multiple doses(At the end of Cycle 1 (each cycle is 28 days))
- Css,min of first 28 days of multiple doses(At the end of Cycle 1 (each cycle is 28 days))
- Tss,max of first 28 days of multiple doses(At the end of Cycle 1 (each cycle is 28 days))
- Vz/F of first 28 days of multiple doses(At the end of Cycle 1 (each cycle is 28 days))
- MRT0-t of single dose(At the end of Cycle 1 (each cycle is 28 days))
- Cmax of single dose(At the end of Cycle 1 (each cycle is 28 days))
- AUC0-t of single dose(At the end of Cycle 1 (each cycle is 28 days))
- Vz/F of single dose(At the end of Cycle 1 (each cycle is 28 days))
- Cav of first 28 days of multiple doses(At the end of Cycle 1 (each cycle is 28 days))
- t1/2 of first 28 days of multiple doses(At the end of Cycle 1 (each cycle is 28 days))
- CLss/F of first 28 days of multiple doses(At the end of Cycle 1 (each cycle is 28 days))
- AUCss of first 28 days of multiple doses(At the end of Cycle 1 (each cycle is 28 days))
- λz of first 28 days of multiple doses(At the end of Cycle 1 (each cycle is 28 days))
- Objective response rate (ORR)(through study completion, an average of 1 year)
- Duration of response (DOR)(through study completion, an average of 1 year)
- Composite response (CRc) rate(through study completion, an average of 1 year)
研究者
研究点 (1)
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